Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: Results of a multicenter, randomized double-blind, controlled study

Background: A fixed-close combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% has been developed for the once-daily treatment of acne. Objective. To evaluate the efficacy and safety of adapalene 0.1% -BPO 2.5% fixed combination gel (adapalene-BPO) for the treatment of acne. Methods: A total of 517 subjects were randomized in a double-blind controlled trial to receive either adapalene-BPO, adapalene, BPO, or vehicle for 12 weeks (2:2:2:1 randomization). Evaluation included Success rate (subjects clear or almost clear), lesion count, cutaneous tolerability, and adverse events. Results: The fixed-close combination gel of adapalene and BPO was significantly more effective than corresponding monotherapies, with significant differences in total lesion counts observed as early as I week. Adverse event frequency and cutaneous tolerability profile for adapalene-BPO were similar to adapalene monotherapy. Limitations: These data were generated in a controlled trial. Results obtained in clinical practice could differ. Conclusions: The fixed-close combination of adapalene and 13110 provides significantly greater efficacy for the treatment of acne vulgaris as early as week I relative to monotherapies, with a coinparable safety profile to adapalene. (J Am Acad Dermatol 2007-157:791-9.)